Regulatory Knowledge At A Glance Regulatory Landscape Resource Center united States of America Key laws, acts, regulations, directives, guidelines, guidance documents, standards and other relevant resources for business development and regulatory professionals in the medical industry. Federal Food, Drug, and Cosmetic Act (FD&C Act) Federal law Code of Federal Regulations Title 21 (21 CFR) FDA regulations Medical Device Databases 21 CFR Part 7 - Enforcement Policy FDA regulation 21 CFR Electronic Records; Electronic Signatures Final Guidance Document 21 CFR Part 801 Labeling FDA regulation 21 CFR Part 803 Medical Device Reporting FDA regulation 21 CFR Part 806 Medical Devices: Report of Corrections and Removals FDA regulation 21 CFR Quality System Regulation FDA regulation 21 CFR Unique Device Identification FDA regulation 510(k) Premarket Notification Database Medical Devices Database Premarket Approval (PMA) Database Medical Devices Database Easy to Understand. Easy To Use. Key Takeaways Determine if your product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act.Determine if an appropriate product classification exists for your productClassify Your Device and Understand Applicable Regulatory ControlsSelect and Prepare the Correct Premarket SubmissionSend your Premarket Submission to the FDA and Interact with FDA Staff During ReviewComply with Applicable Regulatory Controls Including the Establishment Registration and Device Listing Step 1 Strategy Develop a strong and agile regulatory strategy with a long-term view. Step 2 Compliance Ensure compliance with pre-market and post-market requirements. Step 3 Communication Interact and negotiate with regulatory authorities as much as necessary . A point in history The Food, Drug and Cosmetic Laws 1906Pure Food and Drug Act1912Sherley Amendment 1938FD&C Act (elixir sulfanilamide)1944Public Health Service (PHS) Act1951Durham-Humphrey Amendment1958Food Additives Amendment1962Kefauver-Harris Amendment (thalidomide)1976Medical Device Amendments (faulty medical devices had caused 10,000 injuries)1983Orphan Drug Act1984Drug Price Competition and Patent Term Restoration Act1990Safe Medical Devices Act (SMDA)1992Medical Device Amendments1992Prescription Drug User Fee Act (PDUFA I)1997FDA Modernization Act (FDAMA)2011Food Safety Modernization Act (FSMA)2012Food and Drug Administration Safety and Innovation Act2013Drug Quality and Security Act2015Improving Regulatory Transparency for New Medical Therapies Act 201621st Century Act (CCA)2018Right to Try Act Democratizing MedTech Regulatory Knowledge #regulatoryandmore The Shop Share Facebook Twitter Linkedin Whatsapp Envelope Template – Product Qualification and Classification under the EU IVDR 2017/746 (v.1.0) $50.00 Add to cart Checklist – ISO 13485 2016 Internal Audit (v.1.0) $50.00 Add to cart Template – SOP Master Validation Test Plan (v.1.0) $50.00 Add to cart Template – Technical Documentation Table of Content according to the IVDR (v1.0) $50.00 Add to cart Template – SOP Technical Documentation according the IVDR (v1.0) $50.00 Add to cart How to Create a Project Timeline in Simple Steps Read More » How to create a Project Timeline with VisualMaker? Read More » The IVD Product Types: RUO, IUO, GPR, ASR Read More » Claims under the MDR and the IVDR (Art. 7/7) Read More » The Investigational Device Exemption (IDE) Read More » Conformity Assessment Options for Products Failing under the MDR Read More » Follow Us Linkedin Twitter Facebook Instagram